NCT02031900

High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: NinePoint Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.

Conditions

• Undergoing Esophagogastroduodenoscopy (EGD)

Interventions

Type	Name	Description
DEVICE	NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit	The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-01-09
• Last updated: 2014-03-26

Locations

1 site across 1 country: United States